Clinical Trial-Specific Review Criteria

Purpose

For due dates on or after January 25, 2018, NIH requires that all applications involving one or more independent clinical trials be submitted through a funding opportunity specifically designated as "Clinical Trial Required," "Clinical Trial Optional," or "Basic Experimental Studies with Humans Required." These clinical trial–specific funding opportunities include new review criteria questions that focus on the rationale and study design and also include considerations for mechanistic studies, which will inform assessments of the proposed studies.

Applicants proposing to gain clinical trial research experience, but who will not be leading an independent clinical trial, should apply to a funding opportunity designated as "Clinical Trial Not Allowed" or "Independent Clinical Trial Not Allowed". These funding opportunities also include several new review criteria questions focused on how the applicant will receive training in the conduct and design of clinical trial research.

The goal of this policy is to ensure that key pieces of clinical trial-specific information are submitted with each application and that reviewers appropriately consider this clinical trial-related information. Implementing new and more rigorous review criteria for evaluating clinical trial applications will ensure the highest likelihood of translating research results into knowledge that will improve human health.

Policy Implementation

New review criteria questions are effective for all applications proposing clinical trials or proposing to gain clinical trial research experience with due dates on or after January 25, 2018.

Funding Opportunities that accept clinical trials include additional review criteria questions in Section V. Application Review Information. New review criteria questions have been added to the following:

Research (R) Awards

Scored Review Criteria:

• Significance
• Investigator(s)
• Innovation
• Approach
• Environment

Additional Review Criteria:

• Study Timeline  

Individual Career Development (K) Awards

Scored Review Criteria:

• Candidate
• Research Plan
• Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
• Environment & Institutional Commitment to the Candidate

Additional Review Criteria:

• Study Timeline